Duns Number:058614483
Device Description: Pediatric-Infant SpO2 Sensor with Wraps,(1) OXI-P/I, (50) ADH-P/I
Catalog Number
-
Brand Name
Nellcor
Version/Model Number
OXI-P/I
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012891,K012891
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
4ed09124-4b81-4781-8c4c-cd2a4b1ec526
Public Version Date
August 31, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10884522042826
Quantity per Package
50
Contains DI Package
20884522042823
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |